EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/194 rev.4  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for diethofencarb, 
fenoxycarb, flutriafol and pencycuron in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for diethofencarb, 
fenoxycarb, flutriafol and pencycuron in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No  396/2005 of the Euro pean Parliament and of the 
Council of 23  February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article 14(1) , point (a), and Article 18(1) , point (b) thereof,  
Whereas:  
(1) For diethofencarb, fenoxycarb, flutriafol and pencycuron , maximum residue levels 
(‘MRLs ’) were set in Annex  II to Regulation (EC) No  396/2005 .  
(2) The approval of the active substance diethofencarb expired on 31 May 2021 and no 
application for renewal of its approval has been submitted. All authorisations for plant 
protection products containing th at active substance have been revoked.   
(3) The MRL for diethofencarb in and on bananas corresponds to an import tolerance and 
is safe for consumers  at the existing level2. Therefore, this MRL should be maintained  
in Annex II to Regulation (EC) No 396/2005  in accordance with Article 3(2), point (g) 
and Article 14(2), point (e) of Regulation (EC) No 396/2005.  
(4) For diethofencarb in and on pears, wine grapes, tomatoes and aubergines/eggplants,  
the existing MRLs were based on uses in the Union . Following the withdrawal of 
authorisations for these uses of that substance , it is appropriate to delete  those  MRLs 
set for diethofencarb  in Annex II to Regulation (EC) No 396/2005 in accordance with 
Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)  point (a) 
thereof . The MRLs fo r those  products should  therefore  be set at  the limit of 
determination (‘LOD’)  in Annex II to Reg ulation (EC) No 396/2005 in accordance 
with article 18(1)  point (b) of that Regulation . Additionally, as those MRLs are 
deleted, the re is no  need for additional information , therefore,  the respective footnotes 
indicating lack of information on residue trials for pears and wine grapes, and on 
storage stability for pears, wine grapes, tomatoes and aubergines/eggplants should be 
deleted.  
(5) The approval of the active substance fenoxycarb  expired on 31  May 2021 , and no 
application has been submitted for its renewal . All authorisations for plant protection 
products containing th at active substance have been revoked.   
 
1 OJ L 70, 16.3.2005, p. 1.  
2  European Food Safety Authority (EFSA), ‘ Reasoned opinion on the setting of import tolerance for diethofencarb in bananas’. 
EFSA Journal 2016;14(9):4576   
EN 2  EN (6) For fenoxycarb in and on pecans, walnuts, apples, pears, quinces, medlars, 
loquats/Japanese medlars, peaches, plums, table grapes, wine grapes, table olives and 
olives for oil production, the existing MRLs were based on uses in the Union. 
Following the withdrawal of authorisations for these uses of that substance , it is 
appropriate to delete th ose MRLs set  for fenoxycarb  in Annex II to Regulation (EC) 
No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in 
conjunction with Article 14(1)  point (a) th ereof . The MRLs for those  products should  
therefore  be set at  the LOD in Annex V to Regulation (EC) No 396/2005  in 
accordance with article 18(1) point (b) of that Regulation . Additionally,  as those 
MRLs are deleted, the re is no  need for additional information , therefore , the respective 
footnote indicating lack of inform ation on residue trials for table olives should be 
deleted.  
(7) The approval of the active substance flutriafol expired on 31 May 2021. According to 
Commission Implementing Regulation (EU) 2021/7263, an application  for the renewal 
of its approval had been submitted, but w as no longer supported by the applicant . All 
authorisations for plant protection products containing th at active substance have been 
revoked.   
(8) The MRLs for flutriafol in and on table grapes, bananas, tomatoes, sweet peppers/bell 
peppers, lettuces, peanuts/groundnuts , rapeseeds/canola seeds , soyabeans, cotton 
seeds, sorghum, wheat and coffee beans are based on  Codex MRLs  (‘CXLs ’) and are 
safe for consumers  at the existing levels4,5. These MRLs should therefore be 
maintained in accordance with Article 3(2), point ( e) and Article 14(2), point (e) of 
Regulation (EC) No 396/2005.  
(9) The MRL for flutriafol in and on sugar beet roots is based on a use of that substance in 
the Union which is no  longer authorised . Howe ver, the lower CXL that is ava ilable for 
that product is also safe for consumers5. Therefore, this MRL should be lowered to the 
corresponding CXL in Annex II to Regul ation (EC) 396/2005 in accordance with  
Article 3(2), point ( e) and Article 14(2), point (e) of that Regulation.   
(10) The MRLs for flutriafol in and on apples, pears, quinces, medlars, loquats/Japanese 
medlars, cherries (sweet) peaches, plums, wine grapes, strawberries, cucurbits with 
edible peel , cucurbits with inedible peel  and hops  are based on import tolerances and 
are safe for consumers4,6,7,8,9. Therefore, these MRL s should be ma intained at the 
existing level in accordance with Article 3(2), point (g) and Article 14(2), point (e) of 
Regulation (EC) No 396/2005.  
 
3 OJ L 155, 5.5.2021 , p.20.  
4  European Food Safety Authority (EFSA), ‘Reasoned opinion on the review of the existing maximum 
residue levels (MRLs) for flutriafol according to Article 12 of Regulation (EC) No 396/2005’. EFSA 
Journal 2014;12(5):3687  
5  European Food Safety Authority (EFSA), ‘Scientific support for preparing an EU position in the 48th 
Session of the Codex Committee on Pesticide Residues (CCPR)’. EFSA Journal 2016;14(8):4571  
6  European Food Safety Authority (EFSA), ‘Reasoned opinion on the setting of import tolerance for 
flutriafol in strawberries’. EFSA Journal 2016;14(3):4427  
7  European Food Safety Authority (EFSA), ‘Reasoned opinion on the setting of import tolerance for 
flutriafol in cucurbits with edible peel’. EFSA Journal 2016;14(9):4577  
8  European Food Safety Authority (EFSA), ‘Reasoned opinion on the evaluation of confirmatory data 
following the Article 12 MRL review and setting of an import tolerance for flutriafol in cucurbits 
(inedible peel)’. EFSA Journal 2020;18(12):6315  
9  European Food Safety Authority (EFSA), ‘Reasoned opinion on the setting of import tolerance for 
flutriafol in hops’. EFSA Journal 2017;15(7):4875   
EN 3  EN (11) For flutriafol in and on beetroots, mustard seeds , gold of pleasure seeds, barley, rice, 
rye, liver (swine, bovine, sheep, goat, equine, other farmed terrestrial animals), poultry 
(liver, kidney, edible offals other than liver and kidney) , the existing MRLs were 
based on uses in the Union . Following the withdrawal of authorisations for these uses 
of that substance , it is appropriate to delete th ose MRLs set for flutriafol  in Annex II to 
Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 
396/2005 in conjunction with Article 14(1)  point (a) thereof . The MRLs for those  
products should therefore be set at  the LOD in An nex II to Regulation (EC) No 
396/2005 in accordance with article 18(1) point (b) of that Regulation .  
(12) The approval of the active substance pencycuron expired on 31  May 2021 , and  no 
application has been sub mitted for its renewal . All authorisations for plant protection 
products containing pencycuron  have been revoked.  It is therefore appropriate to 
delete the MRLs set for th is substance  in Annex II to Regulation (EC) No 396/2005 in 
accordance with Article 17 of Regulation (EC) No 396 /2005 in conjunction with 
Article 14(1)  point (a) thereof . MRLs for all products should therefore be set at the 
LOD in Annex V to Regulation (EC) No 396/2005  in accordance with article 18(1) 
point (b) of that Regulation . 
(13) The Commission consulted the European Union r eference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . For all the active substances 
covered by this Regulation , those laboratories have proposed product specific LODs 
that are analytically achievable.  
(14) Through the World Trade  Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(15) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(16) A reasonable period should be allowed to elapse before the  new MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to adapt  themselves to the requirements which result from the amendments  
to the relevant MRLs . 
(17) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed . 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II  and V to Regulation (EC) No  396/2005 are amended in accordance wi th the 
Annex to this Regulation.  
Article 2  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the U nion or imported into the U nion 
before [Office of Publications: pleas e insert date 6  months after entry into force of this 
Regulation] . 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union .  
EN 4  EN It shall apply from … [ 6 months after the date of entry into force of this Regulation ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
The President  
 Ursula VON DER LEYEN